FDA hits Global Calcium with warning letter for cGMP violations, blocks US imports
The FDA has issued a warning letter to Global Calcium Limited, a pharmaceutical manufacturer in Tamil Nadu, India, citing significant violations of current Good Manufacturing Practice (cGMP) regulations.
The violations, identified during an inspection from July 29 to Aug. 2, 2024, include failures in quality control, data integrity, facility maintenance, and impurity profiling. As a result, the FDA has deemed the company’s active pharmaceutical ingredients (APIs) adulterated under the Federal Food, Drug, and Cosmetic Act.
The FDA’s inspection revealed that Global Calcium’s quality unit failed to maintain accurate manufacturing records, with investigators uncovering falsified documents and deleted electronic files. Some production records showed simultaneous use of the same equipment for different APIs, and key data was removed during the inspection.
Notably, the company admitted to fabricating records to claim production incentives and stated that files were deleted to avoid scrutiny. The FDA rejected Global Calcium’s response as inadequate, stating that its remediation efforts failed to sufficiently address the extent of data integrity breaches.
In addition to documentation issues, the FDA found poor facility maintenance, including leaks that could have led to contamination of pharmaceutical products. The company’s failure to properly establish impurity profiles for its APIs was also noted, with some impurities going unmonitored during stability studies. The agency criticized Global Calcium’s response, pointing out that it failed to account for previously distributed products that may have been affected by these lapses.
As a consequence of these findings, the FDA has placed Global Calcium on Import Alert 66-40, barring its products from entering the U.S. market as of Dec. 20, 2024. The agency has requested a detailed corrective action plan, including a full reconciliation of API batches manufactured in the past three years, an assessment of product risks, and measures to prevent future violations.
Global Calcium, based in Bangalore, India, operates 14 manufacturing plants across 40-plus acres and supplies specialty APIs, including benzodiazepines, ophthalmics, and oncology compounds, to 80 countries. The company is certified by multiple regulatory bodies, including cGMP, EuGMP, and WHO cGMP, and provides strong regulatory support with CEPs, EDMFs, and USDMFs for several products.